7.3DeviationsfromStandardOperatingProceduresrelatedtothestudyshouldbedocumentedandshouldbeacknowledgedbytheStudyDirectorandthePrincipalInvestigator(s),asapplicable.7.3与专题相关的，对SOP的偏移应当记录并得到SD（PI）的认可。7.StandardOperatingProcedures标准操作规程 7.4StandardOperatingProceduresshouldbeavailablefor,b...
1.1TestFacilityManagement’sResponsibilities机构负责人的职责 1.1.2h)ensure,intheeventofamulti-sitestudy,that,ifneeded,aPrincipalInvestigatorisdesignated,whoisappropriatelytrained,qualifiedandexperiencedtosupervisethedelegatedphase(s)ofthestudy.ReplacementofaPrincipalInvestigatorshouldbedoneaccordingtoestablished...
An OECD Consensus Document on "The Application of the GLP Principles to Field Studies" was subsequently published in 1992 and revised in 1999 [ENV/JM/MONO(99)23]. Among other aspects, this document introduced the concept of a "Principal Investigator" who could assume delegated responsibility for...
Content of the Final Report最终报告的内容Information Concerning the Sponsor and the Test Facility委托方和试验机构的信息) Name and address of the Study Director;) SD的姓名和地址;d) Name and address of the Principal Investigator(s) and the phase(s) of the study delegated, if applicable;) PI的...
of infringement.You must not use the OECD logo,visual identity or cover image without express permission or suggest the OECD endorses your use of the work.Any dispute arising under this licence shall be settled by arbitration in accordance with the Permanent Court of ArbitrationPCAArbitration Rules...
English Cancels & replaces the same document of 11 March 2002 OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING Number 13 Consensus Document of the Working Group on Good Laboratory Practice The Application of the OECD Principles of GLP to the Organisation and Management...
•2.2.3Testfacilitymanagementmeanstheperson(s)whohastheauthorityandformalresponsibilityfortheorganisationandfunctioningofthetestfacilityaccordingtothesePrinciplesofGoodLaboratoryPractice.•2.2.3机构负责人：得到正式授权负责机构按照GLP原则组织和运行的一个或几个人。2.2TermsConcerningtheOrganisationofaTestFacility...
经济合作与发展组织GLP原则SuzhouResearch-LeoLiu-OECDGLPPrinciples 经济合作与发展组织G12、DefinitionsofTerms术语定义2.1GLP:GoodLaboratoryPractice(GLP)isaqualitysystemconcernedwiththe organizationalprocessandtheconditionsunderwhichnon-clinicalhealthandenvironmentalsafetystudiesareplanned,performed,monitored,recorded,archivedan...
arecompliedwith,initstestfacility. 1.1.1机构负责人应对确保机构的运行遵从GLP 原则。 1.1TestFacilityManagement’s Responsibilities机构负责人的职责 1.1.2a)ensurethatastatementexistswhich identifiestheindividual(s)withinatestfacility whofulfilltheresponsibilitiesofmanagementas ...
9.ReportingofStudyResults 报告9.4Statement日期9.4.1AQualityAssuranceProgrammestatementlistingthetypesofinspectionsmadeandtheirdates,includingthephase(s)inspected,andthedatesanyinspectionresultswerereportedtomanagementandtotheStudyDirectorandPrincipalInvestigator(s),ifapplicable.Thisstatementwouldalsoservetoconfirmthatthe...